Method and device for uterine fibroid treatment

ABSTRACT

Methods and devices for both imaging and treating uterine fibroid tumors in one real-time system are provided. One minimally invasive method comprises introducing a sheath into a uterus and determining a location of a fibroid using a visualization element within or on the sheath. Upon identification, a portion of the sheath is steered to position at least one treatment needle at the determined location. The needle is then anchored in uterine tissue and the fibroid treated with the needle.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/347,018 filed Feb. 2, 2006, which claims the benefit ofProvisional Patent Application Nos. 60/710,712, filed Aug. 22, 2005, and60/649,839, filed Feb. 2, 2005, the full disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and methods.More particularly, the invention relates to methods and devices forlocating and treating uterine fibroids.

There are unmet needs in the pathophysiology of the female reproductivetract, such as dysfunctional uterine bleeding and fibroids. Fibroids arebenign tumors of the uterine myometria (i.e., muscle) and are the mostcommon tumor of the female pelvis. Fibroid tumors affect up to 30% ofwomen of childbearing age and can cause significant symptoms such asdiscomfort, pelvic pain, mennorhagia, pressure, anemia, compression,infertility and miscarriage. Fibroids may be located in the myometrium(i.e., intramural), adjacent to the endometrium (i.e., submucosal), orin the outer layer of the uterus (i.e., subserosal). Most commonlyfibroids are a smooth muscle overgrowth that arise intramurally and cangrow to be several centimeters in diameter.

Current treatment for fibroids includes medical treatment with NSAIDS,estrogen-progesterone combinations, and GnRH analogues. Pharmacologictherapy with GnRH analogues is limited due to its side effects, such ashot flashes, vaginal dryness, mood changes and bone density loss.Further, its relatively short time of treatment (e.g., 3 months) offerstemporary shrinkage, wherein the fibroids usually regrow after medicaldiscontinuation. Pharmacologic therapy is relatively ineffective andpalliative rather than curative.

Hysterectomy (i.e., surgical removal of the uterus) is a commontreatment for fibroids. It is performed up to 600,000 times annually inthe United States. Indeed, fibroids are the indication for hysterectomyin up to one third of all cases. Hysterectomy for treating fibroids maybe very effective but has many undesirable side effects such as loss offertility, open surgery, sexual dysfunction, and long recovery time.There is also significant morbidity (e.g., sepsis, hemorrhage,peritonitis, bowel and bladder injury), mortality, and costs associatedwith hysterectomy treatments.

Surgical myomectomy is also an open surgical procedure requiringlaparotomy and general anesthesia in which fibroids are removed. Oftenthese procedures result in significant blood loss and can only remove aportion of the culprit tissue. In the early 1990's there was a growth inadvanced operative laparoscopy techniques and laparoscopic myomectomywas pioneered. However, laparoscopic myomectomy remains technicallychallenging. For example, it requires laparoscopic suturing which isperformed only by the most skilled of laparoscopic gynecologists.Further, prolonged anesthesia time, increased blood loss, and possiblyhigher risk of uterine rupture in pregnancy make laparoscopic myomectomya challenging procedure. Currently, the removal of subserosal orintramural fibroids requires an abdominal approach.

Hysteroscopy (i.e., process by which a thin fiber optic camera is usedto image inside the uterus) may include an attachment to destroy tissue.Hysteroscopic resection is a surgical technique that uses a variety ofdevices (e.g., loops, roller balls, bipolar electrodes) to ablate orresect uterine tissue. The uterus needs to be filled with fluid forbetter viewing and thus has potential side effects of fluid overload.Hysteroscopic ablation is also limited by its visualization techniqueand is thus only appropriate for those fibroids that are submucosaland/or protrude into the uterine cavity.

Uterine artery embolization has also been suggested as an alternativeminimally invasive treatment for fibroids. Uterine artery embolizationwas introduced in the early 1990's and is performed by injecting smallparticles through a groin incision into the uterine artery toselectively block the blood supply to fibroids. Uterine arteryembolization results in reduction of the myoma size from 20-70% at sixmonths. However, side effects of this procedure include pelvicinfection, premature menopause, and severe pelvic pain. In addition,long term MRI data suggest that incomplete fibroid infarction may resultin regrowth of infracted fibroid tissue. Despite much interest inuterine artery embolization, the procedure rates remain low and have notgrown past a few thousand performed per year in the United States. Thismay be due to the fact that interventional radiologists, instead ofgynecologists who know how to diagnose and treat fibroid tumors, are theones who perform uterine artery embolization procedures.

Endometrial ablation, which is primarily a procedure for dysfunctionalor abnormal uterine bleeding, may be used at times for fibroids.Recently there have been many new technologies to perform endometrialablation such as cryo energy, microwave energy, and impedance controlledradiofrequency. Endometrial ablation destroys the endometrial tissuelining the uterus, but does not specifically treat fibroids. Thistechnique is also not suitable for women who desire to bear children.Endometrial ablation remains a successful therapy for dysfunctionaluterine bleeding, but is limited in its ability to treat fibroids.

Myolysis is another alternative minimally invasive technique for fibroidtreatment. Myolysis was first performed in the 1980's in Europe by usinglasers to coagulate tissue, denature proteins, and necrose myometriumwith laparoscopic visualization. This technique has been in use for thepast several years and involves applying energy directly to the myoma.Laparoscopic myolysis can be an alternative to myomectomy, as thefibroids are coagulated and then undergo coagulative necrosis resultingin a dramatic decrease in size. Shrinkage of fibroids has been reportedat 30-50%. In addition there is the obvious economic benefit ofout-patient surgery, rapid recovery, and return to normal lifestyle.However, all laparoscopic techniques are limited by the fact that theycan only see, and therefore only treat, subserosal fibroids.

Needle myolysis is a promising technique whereby a laparoscope is usedto introduce one or more needles into a fibroid tumor under visualcontrol. Bipolar radiofrequency current is then delivered between twoadjacent needles, or monopolar current between a single needle and adistant dispersive electrode affixed to the thigh or back. The aim ofneedle myolysis is to coagulate a significant volume of the tumor andthereby cause it to shrink substantially. The traditional technique isto make multiple passes through different areas of the tumor using thecoagulating needle to destroy many cylindrical cores of abnormal tissue.However, the desirability of multiple passes is mitigated by the risk ofadhesion formation, which is thought to increase with increasing amountsof injured uterine serosa and by the operative time and skill required.

For these and other reasons, it would be desirable to provide aminimally invasive method and device to selectively eradicate fibroidtumors within the uterus. It would be desirable if the method and devicecould locate and treat all types of fibroids in the uterus in a safe andeffective manner with minimum risk and discomfort for the patient. Itwould be further desirable to provide a method and device foreradicating fibroid tumors that combines imaging and treatment in onesimple hand held device. At least some of these objectives will be metby the methods and devices of the present invention describedhereinafter.

2. Description of the Background Art

Relevant references include U.S. Pat. No. 5,456,689 Kresch et al.; U.S.Pat. No. 5,979,453 Savage et al.; U.S. Pat. No. 6,002,968 Edwards; U.S.Pat. No. 6,550,482 Burbank et al.; U.S. Pat. No. 6,626,855 Weng et al.;U.S. Pat. No. 6,716,184 Vaezy et al.; WO 2004/064658; and US2005/0107781. The full disclosures of each of the above references areincorporated herein by reference.

BRIEF SUMMARY OF THE INVENTION

In a first aspect of the present invention, methods for minimallyinvasive identification and treatment of submucosal, intramural, orsubserosal fibroids of the uterus are provided. A sheath, catheter, orprobe may be transcervically introduced into the uterus. A location ofthe fibroid tumor may be determined by using a visualization elementwithin or on the sheath. Preferably, the physician will be able to imagethe tumors transendometrially from within the uterine cavity. Thevisualization element may comprise an ultrasonic element or othervisualization means, such as hysteroscopy, that is capable of producinga visual image. Once having identified the location, a portion of thesheath is steered to position at least one treatment needle at thedetermined location. The needle is anchored within the uterine tissueand the fibroid is treated with the needle. Fibroid treatment may takeseveral forms as discussed in more detail below. Generally, eachindividual fibroid tumor will be navigated to, imaged, targeted andtreated separately. It will further be appreciated that external imagingmay be preformed prior to sheath introduction so as to initially “map”the location of the fibroid tumors.

Anchoring comprises manually positioning and penetrating the treatmentneedle through an endometrium so as to engage the fibroid. Preferably,the visualization element not only provides a field of view for locatingthe fibroid but also provides a field of view for directly observing andverifying needle deployment and fibroid treatment in real-time.Visualization may be aided by steering, rotating, or deflecting thevisualization element independent of the treatment needle so as toprovide a complete view. At least one treatment needle, preferably twotreatment needles, will be anchored in the uterine tissue so that theneedles will remain substantially immobile during the delivery oftreatment. For example, anchoring may comprise deploying at least twotreatment needles in a converging manner so as to pinch the fibroidtherebetween. Alternatively, anchoring may comprise deploying at leasttwo treatment needles in a diverging manner so as to hook the fibroidtherebetween. Still further, anchoring may comprise deploying at leasttwo treatment needles in a telescoping manner.

The uterine fibroid may be treated in several ways. Usually the fibroidwill be treated by delivering ablative energy to the fibroid with theneedle to necrose the tissue. The ablative energy may compriseelectrically energy (e.g., radiofrequency energy, laser energy, ormicrowave energy), freezing energy (e.g., cryo energy), ultrasoundenergy, high intensity focused ultrasound (HIFU), or radiation.Preferably, the treatment needle comprises electrically conductiveelectrodes that deliver ablative radiofrequency energy in a bipolar ormonopolar fashion. In addition to or in lieu of ablative energytreatment, the fibroids may be treated by delivering at least onetherapeutic agent to the fibroid with the needle. Still further, and inaddition to or in lieu of energy and/or drug delivery treatments, thefibroid may be treated by mechanical cutting. For example, the fibroidmay be morcelated with a tip of the needle. The treatment needle orother elements (e.g., non-treatment needle, thermocouple) mayadditionally monitor tissue impedance and/or measure a tissuetemperature so as to aid in diagnosis, blood supply measurement, thermalsignature, tissue targeting, and the like.

In another aspect of the present invention, minimally invasive devicesfor imaging and treating submucosal, intramural, or subserosal fibroidsin one real-time system are provided. The device comprises a sheath,probe, catheter, or other shaft which is adapted for transcervicalintroduction into a uterus. A visualization element is within or on adistal steerable portion of the sheath. The visualization element iscapable of determining a location of a fibroid on wall of the uteruswhile the sheath is in the uterus. Typically, the visualization elementcomprise an ultrasonic transducer. For example, the visualizationelement may comprise a phased array transducer having 64 elements or amechanically scanned transducer. Still further, the element may compriseother visualization means, such as hysteroscopy, that is capable ofproducing a visual image. At least one self-anchoring treatment needleis within or on a distal portion of the sheath. The treatment needle isdeployable against the fibroid whose position has been located by thevisualization element.

The at least one treatment needle, usually two treatment needles, willbe anchored by providing a geometry which inhibits displacement afterthe needles have been deployed. Exemplary geometries include non-linear,such as arcuate, helical, such as cork screw, curved, co-axial,everting, and like configurations. For example, the geometry maycomprises a pair of converging or diverging needles which when deployedin tissue will remain firmly anchored as a result of the opposedgeometry. Such geometries may be conveniently referred to as being“self-anchoring.” Such anchoring needles advantageously provide targetedtreatment of larger volumes (e.g., larger fibroids) with less damage tonon-target tissue. The treatment needle may take on a variety of forms,typically having both extended and retracted configurations, and be madefrom a variety of materials (e.g., nitinol). For example, the treatmentneedle may comprise electrodes, electrosurgical needles, or othertissue-penetrating elements capable of delivering ablativeradio-frequency energy to target and treat the tumors. Alternatively,the treatment needle may comprise an antenna capable of deliveringmicrowave energy to treat the fibroid. Further, the treatment needle maycomprise a hollow tube so as to deliver at least one therapeutic agentto the fibroid. Still further, the treatment needle may comprise acutting tube so as to morcelate the fibroid.

The visualization element will preferably be located near and/or coupledto the treatment needle so that needle positioning, deployment, andtreatment is within a surgeon's field of view. The sheath, visualizationelement, and/or treatment needle may be integrally formed or comprisesseparate, modular components that are coupleable to one another. Forexample, the visualization element may comprise a re-usable ultrasoundcore that may be positioned within a disposable needle carrying sheath.Further, at least a portion of the sheath, visualization element, and/ortreatment needle may be steerable, rotatable, deflectable, flexible,pre-shaped, or pre-formed so as provide transvaginal access to theuterus for identification and treatment of fibroids. An exemplaryinterventional deployment and imaging system is described in more detailin co-pending pending U.S. Provisional Patent Application Ser. No.60/758,881, filed Jan. 12, 2006, which is assigned to the assignee ofthe present application and incorporated herein by reference.

A further understanding of the nature and advantages of the presentinvention will become apparent by reference to the remaining portions ofthe specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings should be read with reference to the detaileddescription. Like numbers in different drawings refer to like elements.The drawings, which are not necessarily to scale, illustratively depictembodiments of the present invention and are not intended to limit thescope of the invention.

FIGS. 1A though 1F illustrate a first embodiment of the method anddevice comprising converging ablation needles and on board ultrasoundimaging constructed in accordance with the principles of the presentinvention.

FIGS. 2A through 2D illustrate a second embodiment of the method anddevice comprising diverging ablation needles and on board ultrasoundimaging constructed in accordance with the principles of the presentinvention.

FIGS. 3A through 3D illustrate a third embodiment of the method anddevice comprising telescoping ablation needles and on board ultrasoundimaging constructed in accordance with the principles of the presentinvention.

FIGS. 4A through 4F illustrate a fourth embodiment of the method anddevice comprising an inflatable balloon which provides treatment and onboard ultrasound imaging constructed in accordance with the principlesof the present invention.

FIGS. 5A through 5C illustrate a fifth embodiment of the method anddevice comprising another inflatable balloon which provides treatmentand on board ultrasound imaging constructed in accordance with theprinciples of the present invention.

FIG. 6 illustrates a sixth embodiment of the method and devicecomprising a mechanical cutting element having a morcelating tip and onboard ultrasound imaging constructed in accordance with the principlesof the present invention.

FIGS. 7A through 7C illustrate a seventh embodiment of the method anddevice comprising drug delivery needles and on board ultrasound imagingconstructed in accordance with the principles of the present invention.

FIG. 8 illustrates an eighth embodiment of the method and devicecomprising laproscopically injecting bubbles containing drugs that areactivated by intra-uteral ultrasound imaging.

FIG. 9A and 9B illustrate impedance monitoring for directed fibroidtreatment which may be employed with the present invention.

FIG. 10 illustrates a method of laproscopically imaging and treating afibroid.

FIGS. 11A through 11C illustrate methods of decoupling the ultrasoundimaging from the steerable, flexible needle catheter.

FIG. 12 illustrates a direct transuteral diagnostic ultrasound imager.

FIGS. 13A and 13B illustrate schematics of a system constructed inaccordance with the principles of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIGS. 1A through 1F, a first embodiment of theinvention is illustrated including two converging ablation needles 14and an ultrasound imaging module 12. A flexible, steerable catheter 10is shown that acts as a sheath for the ultrasound catheter 12. In FIG.1A, the two treatment needles 14 are in a retracted configuration withinthe sheath 10. In FIG. 1 B, the ultrasound catheter 12 is shown withinthe sheath 10 with the two treatment needles 14 in a deployedconfiguration. One or both converging ablation needles 14 may haveinsulating sleeves so as to prevent treating non-target tissue and/orthermocouples at a tip region to measure a tissue temperature. FIG. 1Cshows application of radiofrequency ablation energy between the twobipolar needle electrodes 14 and the resulting energy field 16therebetween. FIG. 1D shows the sheath 10 inserted into the uterus 18via the cervix 20 with a flexible shaft portion 22. As described above,the ultrasound beam 12 not only allows for identification of thefibroids 24, 26, but also serves to provide real-time visualization ofneedle anchoring and ablation treatment. The ultrasound catheter 12 mayfurther be steered, rotated, or deflected independently of the treatmentneedles 14 so as to allow for a complete reconstruction view. Forexample, the ultrasound catheter may be torqued or rotated so thatpositioning of both needles 14 and treatment 16 may be verified. FIG. 1Eshow deployment of the treatment needles 14 during ultrasoundvisualization while FIG. 1F shows radiofrequency ablation treatment 16of the fibroid tumor 24. Generally, each individual fibroid tumor 24, 26will be navigated to, imaged, targeted and treated separately. It willbe appreciated that the above depictions are for illustrative purposesonly and do not necessarily reflect the actual shape, size, ordimensions of the device. This applies to all depictions hereinafter.

Referring now to FIGS. 2A through 2D, a second embodiment of theinvention is illustrated including two diverging ablation needles 28 andthe ultrasound imaging module 12. Again, the flexible, steerablecatheter 10 is shown acting as a sheath for the ultrasound catheter 12.In FIG. 2A, the ultrasound catheter 12 is inserted into the sheath 10and is visualizing the fibroid tumor 24 within the uterus as denoted bythe dashed lines 30. A hollow nitinol needle 32 is deployed through alumen 34 in the sheath 10 as illustrated in FIG. 2B. Thereafter, twohooked treatment needles 28 are deployed through the hollow needle 32 asillustrated in FIG. 2C and anchored against the fibroid 24.Radiofrequency ablative energy is then delivered in a bipolar fashionbetween the two poles of the hooked treatment needles 28 so as tonecrose the fibroid tissue 24 as illustrated in FIG. 2D. Fibroididentification, needle deployment, and ablation treatment are carriedout under ultrasound visualization 30 in real-time. It will beappreciated that the distances (as denoted by arrows 36, 38) that eachtreatment needle 28 is deployed within the fibroid tissue 24 may beadjusted based on the size of the lesion.

Referring now to FIGS. 3A through 3D, a third embodiment of theinvention is illustrated including a telescoping ablation needle 40 andthe ultrasound imaging module 12. Again, the flexible, steerablecatheter 10 is shown acting as a sheath for the ultrasound catheter 12.As shown in FIG. 3A, the ultrasound catheter 12 is inserted into thesheath 10. The sheath 10 is transcervically introduced into the uterusand used for visualizing the fibroid tumor 24 as denoted by the dashedlines 30. Similar to FIG. 2B, a first nitinol needle 32 is deployedthrough the lumen 34 in the sheath 10. Thereafter, a second telescopingneedle 40 is deployed through the first needle 32 as illustrated in FIG.3C. Radiofrequency ablative energy is delivered in a bipolar fashionbetween the two telescoping needles 40, 32 under ultrasoundvisualization 30. Again, the distance (as denoted by arrow 42) that thetelescoping treatment needle 40 is extended within the fibroid tissue 24may be adjustable to the size of the lesion.

Referring now to FIGS. 4A through 4F, a fourth embodiment of theinvention is illustrated including an inflatable treatment balloon 44and the ultrasound imaging catheter 12. As shown in FIG. 4A, theflexible, steerable sheath 10 is inserted into the uterus 18 via thecervix 20 with the ultrasound module 12 on board. The sheath 10 furtherhas a lumen for insertion of a rotary cutting tube 46, treatment needle,or other penetrating device. FIG. 4B illustrates visualization of theindividual fibroid tumor 24 from within the uterine cavity 18 by theultrasound module 12, as denoted by the dashed lines 30. FIG. 4Cillustrates advancement and penetration of the rotary cutting tube 46into the fibroid tumor 24 under direct visualization 30 through theultrasound module 12. The distal end of the rotary cutting tube 46 isdepicted with a morcelating tip 47. In FIG. 4D, some of the fibroidtissue 24 is removed through the rotary cutting tube 46 to create roomfor the treatment balloon 44. The rotary cutting tube 46 is furtherpartially retracted to make room in the tumor 24 for the treatmentballoon 44. As shown in FIG. 4E, the treatment balloon 44 is thendeployed through the cutting tube 46 and into the tumor 24 under directvisualization 30 through the ultrasound module 12. As shown in FIG. 4F,the treatment balloon 44 is inflated and ablative energy is applied bythe balloon 44 to treat the tumor 24 under direct visualization 30through the ultrasound module 12. The ablative energy may comprise anyof the energy sources described herein including radiofrequency energy,microwave energy, laser energy, cryo energy, ultrasound energy, HIFU, orradiation. Alternatively or in addition to the treatment balloon 44, aradiofrequency basket electrode may be disposed over the balloon totreat the tumor.

Referring now to FIGS. 5A through 5C, a fifth embodiment of theinvention is illustrated including the inflatable treatment balloon 44and the ultrasound imaging catheter 12 of FIG. 4F. This embodimentdiffers in how the treatment balloon 44 is deployed into the tumor 24.After identification of the fibroid tumor 24 from within the uterinecavity 18, a rotary cutting tube 48 without a morcelating tip isadvanced and penetrated into the fibroid tumor 24 under directvisualization 30 through the ultrasound module 12 as shown in FIG. 5A. Awire 50 is then advanced into the tumor 24 through the cutting tube 48under direct visualization 30 through the ultrasound module 12 in FIG.5B. In FIG. 5C, the treatment balloon 44 is advanced through the cuttingtube 48 and over the wire 50 and then inflated in the tumor 24 underdirect ultrasound visualization 30 so as to treat the tumor 24 withablative energy. The ablative energy may comprise any of the energysources described herein including radiofrequency energy, microwaveenergy, laser energy, cryo energy, ultrasound energy, HIFU, orradiation.

Referring now to FIG. 6, a sixth embodiment of the invention isillustrated including the rotary cutting tube 46 and the ultrasoundimaging catheter 12 of FIG. 4C. This embodiment differs in that therotary cutting tube 46 itself provides treatment of the tumor 24 withits mechanical cutting element having a morcelating tip 47. Afteridentification of the fibroid tumor 24 and advancement/penetration ofthe rotary cutting tube 46 into the fibroid tumor 24 under directvisualization 30 through the ultrasound module 12 in the uterus 18, thefibroid 24 is morcelated or liquefied by the rotary cutting tube 46 andthe fibroid tissue 24 is suctioned out through the hollow cutting tube46 as depicted by reference numeral 52.

Referring now to FIGS. 7A through 7C, a seventh embodiment of theinvention is illustrated including a drug delivery needle 54 and theultrasound imaging catheter 12. In FIG. 7A, under ultrasoundvisualization in the uterus, two treatment needles 54 are anchoredwithin the fibroid 24 and the fibroid treated by the delivery of atleast one therapeutic agent 56 to the fibroid with the needles 54. Itwill be appreciated that the treatment needles 54 may have both aretracted and extended position and may be adjustable so as to achievethe desired drug delivery profile. Further, drug delivery may take placethough a single treatment needle 54 or through multiple treatmentneedles 54. The therapeutic agent 56 may comprise a variety of agents.For example, the agent 56 may comprise a chemotherapeutic orchemoablative agent (e.g., alcohol or a chemokine), a gene therapyagent, a tissue necrosis agent, an antibody, or the like. The drugdelivery needles 54 may treat tumors of various sizes. For example, FIG.7B illustrates treatment of a large tumor 24′ (e.g., 40 mm), while FIG.7C illustrates treatment of a smaller tumor 24″ (e.g., 20 mm).

Referring now to FIG. 8, another drug delivery method and device isillustrated. A syringe 58 is used to laproscopically inject contrastbubbles 60 containing at least one therapeutic agent 56 into the fibroid24 instead of transcervical drug delivery via treatment needles 54.After drug delivery injection into the fibroid 24, the ultrasoundimaging catheter 12 in the uterus 18 activates the agent 56 by targetedultrasound 30. For example, this may cause the bubbles 60 to burst orbreak in the fibroid blood supply 24 which in turn releases thetherapeutic agent 56 to the fibroid 24 for treatment.

Referring now to FIG. 9A, the flexible, steerable catheter 10 is showninserted into the uterus 18 via the cervix 20. The catheter 10 has an onboard ultrasound imaging module 12 and a lumen for insertion of at leastone needle 62 or other penetrating device. In this illustration,multiple needles 62 are shown inserted into the fibroid tumor 24 withimpedance monitoring to denote the change in the impedance of the tissuefrom inside the tumor 24 versus tissue outside the tumor 24 and/ortissue outside the uterine wall. Impedance monitoring will aid indirectly targeting the fibroid tumor 24 for treatment (e.g., energydelivery, drug delivery, mechanical cutting, etc.) and may also safelycontrol treatment delivery so that it is only within the uterus 18itself Further, impedance profiling may denote border recognition oftissue. This in turn may allow for implementation of additional safetymechanisms. For example, automatic shutoff of the device may beimplemented if the needle 62 is extended beyond the fibroid 24 and/oruterus 18.

Referring now to FIG. 9B, the flexible, steerable catheter 10 is showninserted uterus 18 via the cervix 20. The catheter 10 has an on boardultrasound imaging module 12 and a lumen for insertion of at least oneneedle 64 or other penetrating device. The needle 64 is shown insertedinto the fibroid tumor 24 with impedance monitoring to denote the changein the impedance of the tissue from inside the tumor 24 versus tissueoutside the tumor and/or tissue outside the uterine wall. Impedancemonitoring will aid in directly targeting the fibroid tumor 24 fortreatment from the uterine wall.

Referring now to FIG. 10, a flexible, steerable laparoscopic probe 10 isshown accessing the uterus 18 from an abdominal port 66 in the abdominalwall 68. The probe 10 uses the ultrasound module 12 outside of theuterus 18 to target fibroid tumors 24 that are within the uterus 18. Theprobe 10 then uses the treatment needle 70 under direct visualization 30through the ultrasound module 12 to then treat the fibroid 24 withablative energy.

Referring now to FIG. 11A, a flexible, steerable catheter based probe 10having a treatment needle 72 is shown inserted into the uterus 18 andwithin the fibroid 24 using a non-coupled vaginal ultrasound probe 74.The two devices 10, 74 are operated independently of each other.Referring now to FIG. 11B, the flexible, steerable needle catheter 10 isshown inserted into the uterus 18 and the treatment needle 72 within thefibroid 24 using a non-coupled abdominal ultrasound probe 76. The twodevices 10, 76 are operated independently of each other. With respect toFIG. 11C, the flexible, steerable laparoscopic needle probe 10 is shownaccessing the uterus 18 from an abdominal port 66 in the abdominal wall68. The treatment needle 70 of the probe 10 is shown accessing thefibroid 24 with the aid of ultrasound visualization 30 from theabdominal ultrasound probe 76. The two devices 70, 76 are operatedindependently of each other.

Referring now to FIG. 12, a flexible, steerable intrauterine ultrasoundimaging device 78 is shown for imaging the uterine wall and liningtransendometrially for the diagnosis of fibroids 24, 26. The ultrasoundimaging head 82 generally comprises an ultrasonic phased arraytransducer having 64 elements. The ultrasound transducer may also bemechanical, linear, or curved. A sterile drape 80 may be placed over thediagnostic imager 78, wherein a gel may be used within the drape 80 forimproved image coupling. The diagnostic imager 78 may also be usedwithout a drape 80, when disposable, using natural body fluids for imagecoupling. The diagnostic imager 78 further has a flexible section 84capable of deflection in a range from 0 degrees to about 90 degrees viaan angle adjustment knob 86. The diagnostic ultrasound imager 78 isinserted directly into the uterine cavity 18, either with or withoutdilation of the cervix 20, in order to directly image the fibroids 24,26 within the wall of the uterus 18. This imaging provides a closer andmore direct view of the tumors 24, 46 in order to more accuratelydiagnose the location and characterization of the fibroids or otherpathology.

FIGS. 13A and 13B illustrate schematics of a system constructed inaccordance with the principles of the present invention. The systemcomprises a combined ultrasound recognition and radiofrequency treatmentsystem 88. The system 88 may provide a variety of features includingultrasound mapping, ultrasound recognition of treatment area (e.g.,tissue differentiation via temperature profiling), radiofrequencyablation treatment under ultrasound imaging, temperature monitoring,time monitoring, and/or impedance monitoring. The system 88 may becoupled to various devices 90 described herein having single or multipletreatment needle configurations to ablate in either bipolar or monopolormodes.

Although certain exemplary embodiments and methods have been describedin some detail, for clarity of understanding and by way of example, itwill be apparent from the foregoing disclosure to those skilled in theart that variations, modifications, changes, and adaptations of suchembodiments and methods may be made without departing from the truespirit and scope of the invention. Therefore, the above descriptionshould not be taken as limiting the scope of the invention which isdefined by the appended claims.

1. A method for minimally invasive treatment of uterine fibroids, saidmethod comprising: introducing a sheath into a uterus; determining alocation of a fibroid using a visualization element within or on thesheath; advancing a hollow needle from the sheath through a wall of theuterus; advancing a plurality of diverging needles from the hollowneedle into the fibroid; and treating the fibroid with the divergingneedles.
 2. A method as in claim 1, wherein the sheath is introducedtranscervically.
 3. A method as in claim 1, wherein the visualizationelement is ultrasonic and produces a visual image.
 4. A method as inclaim 3, wherein introducing comprises manually positioning andpenetrating the treatment needle through an endometrium so as to engagethe fibroid.
 5. A method as in claim 1, wherein determining comprisessteering, rotating, or deflecting the visualization element independentof the treatment needle.
 6. A method as in claim 1, wherein treating thefibroid comprises delivering ablative energy to the fibroid with theneedle.
 7. A method as in claim 6, wherein the ablative energy comprisesradiofrequency energy, microwave energy, laser energy, cryo energy,ultrasound energy, HIFU, or radiation.
 8. A method as in claim 7,wherein the ablative energy comprises radiofrequency energy delivered ina bipolar or monopolar fashion.
 9. A method as in claim 1, whereintreating the fibroid comprises delivering at least one therapeutic agentto the fibroid with the needle.
 10. A method as in claim 1, furthercomprising imaging needle anchoring and treatment in real-time with thevisualization element.
 11. A method as in claim 1, further comprisingmonitoring tissue impedance.
 12. A method as in claim 1, furthercomprising measuring a tissue temperature so as to aid in diagnosis,blood supply measurement, thermal signature, or tissue targeting.
 13. Amethod for minimally invasive treatment of uterine fibroids, said methodcomprising: introducing a sheath into a uterus; determining a locationof a fibroid using a visualization element within or on the sheath;advancing a hollow needle from the sheath through a wall of the uterusinto the fibroid; and morcelating the fibroid with the needle.
 14. Amethod as in claim 13, wherein the sheath is introduced transcervically.15. A method as in claim 13, wherein the visualization element isultrasonic and produces a visual image.
 16. A method as in claim 15,wherein introducing comprises manually positioning and penetrating thetreatment needle through an endometrium so as to engage the fibroid. 17.A method as in claim 13, wherein determining comprises steering,rotating, or deflecting the visualization element independent of thetreatment needle.
 18. A method as in claim 13, wherein treating thefibroid further comprises delivering at least one therapeutic agent tothe fibroid with the needle.
 19. A method as in claim 13, furthercomprising imaging needle anchoring and treatment in real-time with thevisualization element.
 20. A method as in claim 13, further comprisingmeasuring a tissue temperature so as to aid in diagnosis, blood supplymeasurement, thermal signature, or tissue targeting.